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Loxo Oncology cancer drug granted US FDA priority review

Stamford, Conn.-based Loxo Oncology Inc. said the U.S. Food and Drug Administration granted priority review to the company's drug larotrectinib as a treatment for certain solid tumors.

The regulator accepted Loxo's application for larotrectinib for treating for adults and children with solid tumors with the neurotrophic tyrosine receptor kinase, or NTRK, gene fusion that locally progressed or already spread across the body.

NTRK gene fusions are genetic alterations that can cause tumor growth.

The FDA grants priority review to therapies that would improve on the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. Once granted, the regulator will take action on the application within 6 months compared to the usual 10 months under standard review.

The FDA is targeting an action date of Nov. 26 for larotrectinib.

The regulator has also previously granted breakthrough therapy designation, rare pediatric disease designation and orphan drug designation to larotrectinib.

Loxo is developing and commercializing larotrectinib with Germany's Bayer AG. Bayer plans to submit a marketing authorization application for the therapy in the EU in 2018.